© Thermoteknix Systems Ltd 2020
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This equipment is not designed or intended for use as a medical device. This device
is not FDA-cleared or approved. However, as a telethermographic device originally
intended for industrial, construction and commercial use it can be repurposed to
assist in initial screening for fever and triage of individuals in high traffic areas such
as airports and businesses under guidance issued by the US Food and Drug
Administration (FDA).
https://www.fda.gov/media/137079/download
These guidelines are in accordance with ISO Standard:
BS (EN) IEC 80601-2-59:2019
“Safety an essential performance of screening thermographs for human febrile
temperature screening.”
Users should operate the system in accordance with the operating guidelines to
maintain full ISO compliance. These guidelines are given in:
PD ISO/TR 13154:2017
“Deployment, implementation and operational guidelines for identifying febrile
humans using a screening thermograph.
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